On April 6, 2022 Selecta Biosciences, Inc. (Nasdaq: SELB) ("Selecta" or the "Company"), a biotechnology company focused on developing tolerogenic therapies to mitigate unwanted immune responses, reported that it has agreed to sell 27,428,572 shares of its common stock and accompanying warrants to purchase up to 20,571,429 shares of common stock at a combined offering price of $1.41 per share and accompanying warrant (Press release, Selecta Biosciences, APR 6, 2022, View Source [SID1234611564]). The warrants to purchase shares of common stock have an exercise price of $1.55 per share, are immediately exercisable and will expire five years from the date of issuance. All of the securities in the offering will be sold by Selecta. The gross proceeds to Selecta from the offering, before deducting underwriting discounts and commissions and other offering expenses, are expected to be approximately $38.7 million. The offering is expected to close on April 11, 2022, subject to the satisfaction of customary closing conditions.

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SVB Leerink is acting as sole bookrunning manager for the offering. Canaccord Genuity is acting as lead manager for the offering.

The offering is being made pursuant to a shelf registration statement on Form S-3 (File No. 333-241692) that was previously filed with the Securities and Exchange Commission (the "SEC") on August 6, 2020 and declared effective on August 14, 2020. A final prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website located at View Source When available, copies of the final prospectus supplement and accompanying prospectus may also be obtained by contacting SVB Securities LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800) 808-7525, ext. 6105, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of Selecta’s securities, nor shall there be any sale of Selecta’s securities in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state.

On April 6, 2022 Geron Corporation (Nasdaq: GERN), a late-stage biopharmaceutical company focused on the development and commercialization of treatments for hematologic malignancies, reported that John A. Scarlett, M.D., Geron’s Chairman and Chief Executive Officer, plans to present a company overview at the 21st Annual Needham Virtual Healthcare Conference on Wednesday, April 13, 2022 at 3:45 p.m. ET (Press release, Geron, APR 6, 2022, View Source [SID1234611563]).

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A live webcast of the presentation will be available through the Investor Relations section of Geron’s website under Events. Following the presentation, the webcast will be archived and available for replay for a period of 30 days.

On April 6, 2022 BiOneCure Therapeutics, Inc. reported that the U.S. Food and Drug Administration (FDA) has cleared the IND for BIO-106, an antibody-drug conjugate (ADC) designed to target TROP-2 to treat a broad range of advanced solid tumors (Press release, BiOneCure Therapeutics, APR 6, 2022, View Source [SID1234611556]).

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The clinical study cleared by the FDA, known as StarBridge-1, is a Phase I/II, multicenter, open-label study to evaluate the safety, pharmacokinetics and preliminary anti-tumor activity of BIO-106 as monotherapy and in combination with pembrolizumab in patients with advanced cancers

This IND approval is a significant milestone for both our team and the patients we hope to serve.

"This is the first IND approval for BiOneCure. It is a significant milestone for both our team and the patients we hope to serve." said Haifeng Bao, Ph.D., Co-founder and Chief Executive Officer at BiOneCure. "BiOneCure has complete intellectual property rights of the product, covering the payload, antibody and the ADC drug product, The introduction of our innovatively developed ADC candidate BIO-106 validated our approach to the next generation of ADC. We are very excited to bring the new molecule to the clinical stage and look forward to advancing this trial"

About BIO-106
BIO-106 is an anti-Trop-2 ADC to target cancer cells expressing Trop-2, a protein overexpressed in a broad range of tumors including TNBC, HR+/HER2 mBC, NSCLC, and others. BIOneCure has developed BIO-106 using its proprietary TAMTM payload technology to enable homogenous high drug load. In the pre-clinical study, BIO-106 has demonstrated broad anti-tumor activities with excellent safety profile and wide therapeutic window.

On April 6, 2022 CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers in the brain and central nervous system, reported it has received approval from the National Agency for the Safety of Medicine and Health Products (ANSM) Competent Authority and from the People Protection Ethics Committee (EC) SUD-EST III (CPP Sud-Est III) in France for the Company’s potentially pivotal study of Berubicin for the treatment of recurrent glioblastoma multiforme (GBM), one of the most aggressive types of brain cancer (Press release, CNS Pharmaceuticals, APR 6, 2022, View Source [SID1234611554]).

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"Access to patients is the lifeblood of any clinical study and this approval, in the second most populous country in Europe, provides just that for our Berubicin trial. We have said time and again that our number one priority is the advancement of this potentially pivotal study. This is evidenced by our continuous dedication to driving enrollment and bringing global clinical sites on line. We are grateful to the French Competent Authority and Ethics Committee and their positive feedback on what we believe is an incredibly important clinical program. Across the globe there is an urgent need for GBM treatment options. We will continue to press on in our efforts to advance Berubicin through the clinic and importantly, to patients and their families. I am proud of the progress our team has made to-date and believe there are additional clinical sites to join those that have already been added to this globlal potentially pivotal study," commented John Climaco, CEO of CNS Pharmaceuticals.

Dr. Carole Gourmelon, MD, Institut de Cancérologie de l’Ouest, St Herblain, added, "GBM is a devastating disease with significant unmet need. I have been encouraged by the data Berubicin has demonstrated to date and look forward to further evaluating its potential to provide benefit to patients. Now with the necessary approvals received, I look forward to joining the Company’s efforts to progress Berubicin through the clinic."

Berubicin is a novel anthracycline and the first anthracycline to appear to cross the blood-brain barrier currently being evaluated in a potentially pivotal global study evaluating its efficacy and safety in the treatment of GBM. The potentially pivotal global trial is an adaptive, multicenter, open-label, randomized and controlled study in adult patients with recurrent glioblastoma multiforme (WHO Grade IV) after failure of standard first-line therapy. Approximately 243 patients with GBM after failure of standard first line therapy will be randomized in a 2:1 ratio to receive Berubicin or lomustine for the evaluation of Overall Survival, the primary endpoint of the study. Overall Survival is a rigorous endpoint that the U.S. Food and Drug Administration (FDA) has recognized as a basis for approval of oncology drugs when a statistically significant improvement can be shown relative to a randomized control arm.

A pre-planned, non-binding futility analysis will be performed after approximately 30 to 50% of all planned patients have completed the primary endpoint at 6 months. This review will include additional evaluation of safety as well as secondary efficacy endpoints. Enrollment will not be paused during this interim analysis.

The FDA recently granted CNS Pharmaceuticals Fast Track Designation for Berubicin which enables more frequent interactions with the FDA to expedite the development and review process. As previously announced, the Company also received Orphan Drug Designation from the FDA which may provide seven years of marketing exclusivity upon approval of an NDA.

For more information about the potentially pivotal Berubicin trial, visit clinicaltrials.gov and reference identifier NCT04762069.

About Berubicin

Berubicin is an anthracycline, a class of anticancer agents that are among the most powerful chemotherapy drugs and effective against more types of cancer than any other class of chemotherapeutic agents. Anthracyclines are designed to utilize natural processes to induce deoxyribonucleic acid (DNA) damage in targeted cancer cells by interfering with the action of topoisomerase II, a critical enzyme enabling cell proliferation. Berubicin treatment of brain cancer patients appeared to demonstrate positive responses that include one durable complete response in a Phase 1 human clinical trial conducted by Reata Pharmaceuticals, Inc. Berubicin, was developed by Dr. Waldemar Priebe, Professor of Medicinal Chemistry at The University of Texas MD Anderson Cancer Center.

On April 6, 2022 AffyImmune Therapeutics, Inc., a clinical stage biotechnology company using its Tune & Track platform to develop CAR T cells for the treatment of solid cancers, reported that it will present an abstract in a poster session at the 2022 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in New Orleans, Louisiana, which is being held April 8 – 13 (Press release, AffyImmune Therapeutics, APR 6, 2022, View Source [SID1234611550]). Presented findings will highlight research using AffyImmune’s Tune & Track platform for the affinity tuning of the interaction between CAR T cells and cancer antigen, tracking of CAR T cells in real-time, and armoring of CAR T cells with cytokines.

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Details of the abstract and poster are as follows:

Title: Focused IL-12 cytokine delivery enhances function of affinity-tuned and real-time tracked ICAM-1-specific CAR T cells in solid tumors
Presenting Author: Michael Gallagher, PhD, Scientist
Session Category: Adoptive Cell Therapy 1
Poster Number: 558/12
Abstract Number: 4978
Presentation Type: Poster
Date, Time, and Location: Sunday, April 10, 1:30 – 5:00 pm, Poster Section 36